Clean Utilities Lead

Discover International; Frankfurt; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Discover International is seeking a Clean Utilities Lead to support sterile manufacturing projects in Germany, focusing on aseptic fill-finish, vial production, GMP utilities, cleanrooms and process equipment interfaces.

You will lead clean utilities design and delivery, coordinate technical interfaces with process equipment, HVAC, CQV and construction teams, and ensure compliance with GMP, Annex 1 and hygienic design.

Qualifikationen

• Experience in clean utilities for pharma/biotech projects.
• Experience with sterile fill-finish, vial or GMP facilities.
• Knowledge of WFI, purified water, clean steam, gases, CIP/SIP.
• Familiar with P&IDs, URS, specifications and vendor packs.
• Understanding of cleanrooms, hygienic design and classified areas.
• Ability to coordinate across design, construction, CQV and vendors.
• Fluent German and English.
• Willing to travel for project requirements.

Aufgaben

• Lead clean utilities scope for sterile fill-finish and aseptic manufacturing projects.
• Support design and delivery of WFI, purified water, clean steam, process gases, CIP/SIP and related GMP utility systems.
• Coordinate technical interfaces with process equipment, HVAC, cleanrooms, automation, CQV and construction teams.
• Review P&IDs, URS, layouts, specifications, vendor packages and technical deliverables.
• Support integration of utilities with vial filling lines, isolators/RABS, washers, depyrogenation tunnels, lyophilisers, cappers, inspection and packaging systems.
• Manage technical queries, design reviews, vendor coordination, risks, changes and project actions.

Kenntnisse

Clean utilities engineering

GMP utilities

Aseptic manufacturing

WFI & purified water

P&IDs & URS

German & English

Jobbeschreibung

An exciting opportunity to join an international engineering organisation delivering complex pharmaceutical and biotech projects across Europe and globally.

We are looking for a Clean Utilities Lead to support sterile manufacturing projects in Germany, with a focus on aseptic fill-finish, vial production, GMP utilities, cleanrooms and process equipment interfaces. This role is suited to someone who can lead clean utilities design and delivery, coordinate technical interfaces, and support project execution across design, construction, commissioning and CQV phases.

Responsibilities

• Lead clean utilities scope for sterile fill-finish and aseptic manufacturing projects.
• Support design and delivery of WFI, purified water, clean steam, process gases, compressed air, CIP/SIP and related GMP utility systems.
• Coordinate technical interfaces with process equipment, HVAC, cleanrooms, automation, CQV and construction teams.
• Review P&IDs, URS, layouts, specifications, vendor packages and technical deliverables.
• Support integration of utilities with vial filling lines, isolators/RABS, washers, depyrogenation tunnels, lyophilisers, cappers, inspection and packaging systems.
• Manage technical queries, design reviews, vendor coordination, risks, changes and project actions.
• Ensure clean utilities design and installation align with GMP, Annex 1, hygienic design, EHS, quality and client requirements.
• Support FAT/SAT, installation, commissioning, qualification readiness and handover.
• Work closely with EPCMV teams, equipment vendors, contractors and client stakeholders.
• Provide clear technical updates and support issue resolution throughout project delivery.

Requirements

• Clean utilities engineering experience within pharmaceutical, biotech or life sciences projects.
• Experience supporting sterile, aseptic, fill-finish, vial or GMP manufacturing facilities.
• Strong knowledge of WFI, purified water, clean steam, process gases, compressed air, CIP/SIP and distribution systems.
• Good understanding of P&IDs, URS, specifications, layouts, vendor documentation and GMP utility design.
• Understanding of cleanroom environments, contamination control, hygienic design and classified areas.
• Experience coordinating with process, HVAC, automation, CQV, construction and vendor teams.
• Ability to support projects across design, construction, commissioning and qualification interfaces.
• Strong technical coordination, documentation and stakeholder management skills.
• Fluent German and English required.
• Willingness to travel for project requirements.